We agree that metal-on-metal hip implants need more regulation to ensure their safety, and that manufacturers should not gain retroactive immunity if a device is ultimately approved through a PMA.
New York, New York (PRWEB) May 07, 2013
Bernstein Liebhard LLP notes that the American Association for Justice, a plaintiff lawyers' industry group, recently weighed in on a proposed plan to subject metal-on-metal hip implants to greater regulatory oversight. According to a May 7th Reuters report, the group submitted a letter to the U.S. Food & Drug Administration (FDA) on April 18th voicing cautious support for a proposed regulation that would require all-metal hip manufacturers to conduct more extensive safety review of their products in order to continue selling the devices or to bring new ones to market. However, the Association also pressed the FDA to include language in any final regulation that would prevent manufacturers from using any subsequent approval through the Premarket Approval (PMA) process to defeat any metal-on-metal hip replacement lawsuits that were filed before the process changes.*
“We applaud the American Association for Justice for bringing this important issue into focus. We agree that metal-on-metal hip implants need more regulation to ensure their safety, and that manufacturers should not gain retroactive immunity if a device is ultimately approved through a PMA,” says Bernstein Liebhard LLP, a nationwide law firm representing the victims of defective drugs and medical devices. The Firm continues to offer free legal evaluations to alleged victims of metal-on-metal hip replacement devices.
Metal-on-Metal Hip Replacement Lawsuits
The FDA has been investigating metal-on-metal hip replacements since February 2011, amid concerns that metal ions shed from the hips can result in metallosis, adverse local tissue reactions, and early failure of the device. In January, the agency issued new guidance for patients fitted with metal-on-metal hip replacements, advising doctors to consider metal ion testing in those experiencing symptoms of hip implant failure. The FDA also said it had proposed a new rule that would make all-metal hips ineligible for 510(k) approvals. Such approvals allow a device to come to market without human testing if a manufacturer can demonstrate that it is similar in design to a previously approved product.**
According to Reuters, the American Association for Justice is concerned that once the FDA adopts the proposed rule, metal-on-metal hip implant manufacturers will attempt to use the legal precedent set in Riegel v. Medtronic to have personal injury claims retroactively dismissed. That 2008 Supreme Court decision found that most personal injury lawsuits involving a device approved through the more-rigorous premarket approval process are pre-empted by federal law.
Bernstein Liebhard LLP is currently representing hundreds of clients in metal-on-metal hip replacement lawsuits whose cases could be impacted by the FDA’s final ruling. The Firm is actively filing claims in the multidistrict litigation established in the U.S. District Court, Northern District of Ohio, for actions involving the DePuy ASR hip implant (In re: DePuy Orthopaedics, Inc. ASR Hip Implant Products Liability Litigation – MDL 2197). Bernstein Liebhard LLP partner Jeffrey S. Grand is also serving on the Plaintiffs’ Steering Committee in the Pinnacle hip litigation now underway in the Northern District of Texas concerning the metal-on-metal DePuy Pinnacle hip device (In re: DePuy Orthopaedics, Inc. Pinnacle Hip Implant Products Liability Litigation - MDL No. 2244).
In addition, the Firm is representing clients fitted with the Biomet M2a Magnum hip implant in a multidistrict litigation underway in U.S. District Court, Northern District of Indiana (In re: Biomet M2a Magnum Hip Implant Products Liability Litigation – MDL No. 2391). Bernstein Liebhard LLP’s attorneys have also filed lawsuits on behalf of individuals affected by the Stryker hip recall for Rejuvenate and ABG II hip stems in a multicounty litigation now moving forward in New Jersey Superior Court. (In re Stryker Rejuvenate Hip Stem and the ABG II Modular Hip Stem Litigation, No. 296). The Firm is also representing alleged victims of injuries resulting from the Wright Conserve hip replacement, as well as the Wright Profemur hip implant.
Victims of metallosis, hip implant failure, and other serious complications allegedly associated with the metal-on-metal hip replacements may be entitled to compensation for their medical bills, lost wages, pain and suffering, and other damages. For more information on filing a metal-on-metal hip implant lawsuit, please visit Bernstein Liebhard’s website. For additional information, please contact one of our attorneys today by calling 1-877-779-1414.
About Bernstein Liebhard
Bernstein Liebhard LLP is a New York-based law firm exclusively representing injured persons in complex individual and class action lawsuits nationwide since 1993, including those who have been harmed by dangerous drugs, defective medical devices and consumer products. The firm has been named by The National Law Journal to the “Plaintiffs’ Hot List,” recognizing the top plaintiffs’ firms in the country, for the past 10 consecutive years.
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ATTORNEY ADVERTISING. © 2013 Bernstein Liebhard LLP. The law firm responsible for this advertisement is Bernstein Liebhard LLP, 10 East 40th Street, New York, New York 10016, (212) 779-1414. Prior results do not guarantee or predict a similar outcome with respect to any future matter.
Felecia L. Stern, Esq.
Bernstein Liebhard LLP